NDC 58443-0242

Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff

Pyrithione Zinc 1%

Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff is a Topical Shampoo in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Pyrithione Zinc.

• Product ID: 58443-0242_3f235977-62ce-08f5-e054-00144ff8d46c
• NDC: 58443-0242
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff
• Generic Name: Pyrithione Zinc 1%
• Dosage Form: Shampoo
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-10-07
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part358H
• Labeler Name: Prime Enterprises Inc.
• Substance Name: PYRITHIONE ZINC
• Active Ingredient Strength: 10 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0242-5

266 mL in 1 TUBE (58443-0242-5)

• Marketing Start Date: 2016-10-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0242-5 [58443024205]

Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff SHAMPOO

• Marketing Category: OTC monograph final
• Application Number: part358H
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-07

Drug Details

Active Ingredients

Ingredient	Strength
PYRITHIONE ZINC	10.32 mg/mL

OpenFDA Data

• SPL SET ID: 3f235977-62cd-08f5-e054-00144ff8d46c
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • R953O2RHZ5

NDC Crossover Matching brand name "Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff" or generic name "Pyrithione Zinc 1%"

NDC	Brand Name	Generic Name
58443-0242	Australian Gold	Pyrithione Zinc 1%
41250-281	Dandruff	Pyrithione zinc 1%
69772-141	HEAD AND SHOULDERS	PYRITHIONE ZINC 1%
64024-006	Lacura Everyday Clean 2in1Dandruff Plus Conditioner	Pyrithione Zinc 1%
64024-005	Lacura Everyday Clean Dandruff	Pyrithione Zinc 1%